MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP CPR COMPLETE ADULT/CHILD ELECTRODE; ELECTRODES

Model Number	8900-000406-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the electrodes would not adhere to the patient's skin while the clinician was performing chest compressions.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The actual electrodes from the event were not returned as part of this investigation.Instead, electrodes from retained samples of the same lot number 4218 were evaluated.The retained sample was subjected to adhesion test, pin to pin continuity testing, and shock testing.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP CPR COMPLETE ADULT/CHILD ELECTRODE
• Common Device Name: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8168967
• Report Number: 1218058-2018-00105
• Device Sequence Number: 1697052
• Product Code: MKJ
• UDI-Device Identifier: 10847946021167
• UDI-Public: 10847946021167
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/15/2020
• Device Model Number: 8900-000406-01
• Device Catalogue Number: 8900-000406-01
• Device Lot Number: 4218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1